Symlin

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Symlin

INDICATIONS

SYMLIN is indicated as an adjunctive treatment in
patients with type 1 or type 2 diabetes who use mealtime insulin therapy and
who have failed to achieve desired glucose control despite optimal insulin
therapy.

DOSAGE AND ADMINISTRATION

Important Considerations Pertaining To SYMLIN And Insulin
Dose Adjustments

SYMLIN should be used only in patients who can fully
understand and adhere to proper insulin adjustments and glucose monitoring.

Insulin and SYMLIN dose adjustments should be made only
as directed by a healthcare professional skilled in the use of insulin.

When initiating SYMLIN, reduce mealtime insulin doses,
including premixed insulins, by 50% to reduce the risk of hypoglycemia.

To reduce the risk of nausea, wait at least 3 days before
titrating SYMLIN to the next dose increment.

Monitor blood glucoses frequently, including pre-and
post-meals and at bedtime, particularly when initiating SYMLIN or increasing
the SYMLIN dose. After the initial 50% reduction in mealtime insulin dose,
individualize insulin dose adjustments based on glycemic control and
tolerability (e.g., if nausea occurs it may affect the dose of insulin
required). An increased frequency of mild-to-moderate hypoglycemia should be
viewed as a warning sign of increased risk for severe hypoglycemia.

If SYMLIN therapy is discontinued for any reason (e.g.,
surgery or illnesses), the same initiation protocol should be followed when
SYMLIN therapy is reinstituted [see below].

Patients With Type 2 Diabetes Using Mealtime Insulin

Increase the SYMLIN dose from 60 to 120 mcg prior to each
major meal when no clinically significant nausea has occurred for at least 3
days.

If significant nausea persists at the 120 mcg dose, the
SYMLIN dose should be decreased to 60 mcg.

Patients With Type 1 Diabetes

Reduce mealtime insulin doses by 50%, then initiate
SYMLIN at 15 mcg subcutaneously, injecting immediately prior to each major
meal.

Increase the SYMLIN dose to the next increment (30, 45,
or 60 mcg) when no clinically significant nausea has occurred for at least 3
days.

If significant nausea persists at the 45 or 60 mcg dose
level, the SYMLIN dose should be decreased to 30 mcg. If the 30 mcg dose is not
tolerated, discontinuation of SYMLIN therapy should be considered.

Administration

SYMLIN should be administered subcutaneously immediately
prior to each major meal ( ≥ 250 kcal or containing ≥ 30 grams of
carbohydrate).

SYMLIN should be at room temperature before injecting to
reduce potential injection site reactions. Each SYMLIN dose should be
administered subcutaneously into the abdomen or thigh. Administration into the
arm is not recommended because of variable absorption. Injection sites should
be rotated so that the same site is not used repeatedly. The injection site
selected should also be distinct from the site chosen for any concomitant insulin
injection.

SYMLIN and insulin should always be administered as
separate injections.

SYMLIN should not be mixed with any type of insulin.

If a SYMLIN dose is missed, wait until the next scheduled
dose and administer the usual amount.

Storage And Handling

SYMLIN pen-injectors not in use: Refrigerate (2°C
to 8°C; 36°F to 46°F), and protect from light. Do not freeze. Do not use if
product has been frozen. Unused SYMLIN (opened or unopened) should not be used
after the expiration (EXP) date printed on the carton and the label.

SYMLIN pen-injectors in use: After first use,
refrigerate or keep at a temperature not greater than 86°F (30°C) for 30 days.
Use within 30 days, whether or not refrigerated.